The following data is part of a premarket notification filed by Paladin Biomedical Corporation with the FDA for Thermostat 900 Administration Set, Model Ash 100, 200 And 300.
| Device ID | K073363 |
| 510k Number | K073363 |
| Device Name: | THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300 |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | PALADIN BIOMEDICAL CORPORATION 506 BOSTON POST ROAD Weston, MA 02493 |
| Contact | Robert Bickford |
| Correspondent | Robert Bickford PALADIN BIOMEDICAL CORPORATION 506 BOSTON POST ROAD Weston, MA 02493 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-30 |
| Decision Date | 2008-03-20 |
| Summary: | summary |